EC grants Astria’s OMPD to navenibart for HAE

Astria Therapeutics announced that the European Commission EC as granted Orphan Medicinal Product Designation OMPD to navenibart for the treatment of hereditary angioedema HAE. Navenibart is a monoclonal antibody inhibitor of plasma kallikrein designed to provide long-acting attack prevention for HAE. Initial results from the Phase 1b/2 ALPHA-STAR clinical trial of navenibart have demonstrated a favorable safety and tolerability profile and a reduction of monthly attack rates by 90-96% when dosed once or twice over six months. “We are very pleased to receive Orphan Medicinal Product Designation for navenibart in Europe,” said Jill C. Milne, Ph.D., Chief Executive Officer. “We believe that OMPD status, in combination with the FDA’s designation of navenibart as an orphan drug in the United States, reinforces both the global unmet need for people with HAE and the potential for navenibart to change the way that people live with HAE. We look forward to the expected progression of navenibart into a Phase 3 trial in the first quarter of 2025 and continuing our efforts to bring a new treatment option to people living with HAE around the world.” I